Spain (Remote with occasional in‑person activities)

We are looking for an experienced and technically skilled Regulatory Affairs professional with a strong focus on clinical evaluation, medical writing and technical documentation for medical devices to join our growing consulting team.

As a Technical Expert – Clinical Evaluation & Technical Documentation, you will contribute to the preparation, review and assessment of clinical, technical and regulatory documentation, helping medical device manufacturers demonstrate compliance with applicable regulatory requirements.

You will contribute to a variety of international client projects, working closely with regulatory consultants and other specialists within multidisciplinary teams.

This role is idóneo for professionals with3–5 years of experiencewho enjoy scientific and technical work, critical analysis and solving complex regulatory challenges within a collaborative consulting environment.

Support the preparation and review of Quality Management System (QMS) documentation and procedures, when required.

You will enjoy a high degree of autonomy in your technical work while receiving support from a collaborative team of experienced regulatory and clinical specialists.

3–5 years of experiencein medical device regulatory affairs, clinical evaluation or technical documentation.

- Bachelor's degree (or higher) in Health Sciences, Biomedical Engineering, Biology, Pharmacy or a related discipline.
- Excellentscientific and technical writing skills, including the ability to critically assess, interpret and synthesise scientific evidence.
- Strong knowledge of EU MDR requirements and medical device technical documentation.
- Experience preparing,



reviewing or assessing technical and regulatory documentation for medical devices.
- Fluent English (written and spoken).
- Availability for remote work with occasional travel, when required.

Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366 or other applicable medical device standards.

Experience working with Software as a Medical Device (SaMD) or AI-based medical devices.

Spanish and/or Portuguese.

You work autonomously, take ownership of your deliverables and are comfortable contributing to several projects simultaneously. You have a critical mindset, strong attention to detail and a commitment to delivering high-quality technical work.

High-impact consulting projects with leading MedTech innovators

Exposure to international regulatory and quality challenges

Continuous professional development and training

Collaboration with experienced specialists across Regulatory Affairs, Clinical Research, Medical Writing, and Quality Assurance

Flexible remote working environment

MDx CRO is a leading Contract Research Organisation specialising in medical devices and in vitro diagnostics (IVDs). We provide regulatory consulting, clinical research, medical writing, and quality assurance services, helping manufacturers bring innovative healthcare technologies to market while ensuring full compliance with global regulatory requirements.

Make it POSSIBLE

Make it WIN-WIN

Keep it DIVERSE

We pioneer emerging technologies and navigate uncharted territories to redefine the future of the medical sector.

If you are looking to take the next step in your Regulatory Affairs and Quality Assurance career, enjoy working with innovative medical technologies, and want to make a meaningful impact through consulting, we'd love to hear from you.

#

📌 IT Support Analyst (English-Speaking) (España)
🏢 MDx CRO
📍 España